Users Manual

2 | iASSIST 2-Pod Version Surgical Technique
1.1 Indication for Use
The iASSIST™ Knee System is a computer assisted
stereotaxic surgical instrument system to assist
the surgeon in preparing the bone surfaces for
positioning orthopedic implant system components
intra-operatively. It involves surgical instruments
and inertial sensors to determine alignment axes in
relation to anatomical landmarks and to precisely
position alignment instruments and cut guides relative
to these axes.
The present iASSIST Knee System is designed for Total
Knee Arthroplasty.
1.2 Training
Prior to using the system, surgeons should follow a
training given by Zimmer CAS or the distributor for the
given applications. Contact your local Zimmer Biomet
representative.
Warning: The system should only be used by
trained surgeons.
1.3 Implant Indications
The prosthesis implanted with the system must be
used in accordance with the appropriate package
insert labeling.
The procedure is to be performed in accordance with
the corresponding surgical technique published by
the manufacturer for the specic implant.
The iASSIST Knee System has only been veried for
use with Zimmer Biomet NexGen Knee and Persona
Knee implant lines.
Warning: The system should only be used with the
instruments provided by Zimmer CAS or by the
distributor for the given application.
1.4 Contraindications
1.4.1 Clinical
The system should not be used:
• In cases of hip pathology severely limiting range
of motion (e.g. arthrodesis, severe contractures,
chronic severe dislocation);
• In cases of hip joint pathology or knee pathology
with signicant bone loss (e.g. avascular necrosis
of the femoral head with collapse, severe dysplasia
of the femoral head or the acetabulum, femoral
condyle collapse);
• For femoral anterior cut rst surgical techniques;
• For total knee arthroplasty using the
Quad-Sparing™ technique; or
• For any other contraindicated case, as given
by the implant manufacturer.
1.4.2 General
The system should not be used:
• On a moving vehicle, or any mobile platform; or
• To perform surgical procedures other than those
specied in the surgical technique dened in this
document.
1.5 Complications
Possible complications associated with the use of
the system may include but are not limited to the
following:
• Infection; and
• Misplacement of the implants potentially
leading to dislocation, impingement or
leg length discrepancy.
The occurrence of one of these complications may
aect the patient’s mobility.
1.6 Target Population and Clinical
Performance
The iASSIST Knee System is designed for use on a
skeletally mature patient population.
The system is designed to provide an HKA (Hip-Knee-
Ankle) angle within ±3° of the surgical plan cut decided
by the surgeon intra-operatively in 90% of the cases.
1.6 Reporting Problems
The user and/or patient should report any suspected
serious incident related to the device by informing
the manufacturer and the competent authority of
the member state in which the serious incident has
occurred.
1.Overview